Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity.
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ABSTRACT:
SUBMITTER: Van Spall HGC
PROVIDER: S-EPMC7989536 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The rapid development and roll-out of coronavirus disease 2019 (COVID-19) vaccines is providing hope for a way to control the pandemic. As pregnant and lactating women are generally excluded from clinical trials, the vaccination programme was launched without adequate safety and efficacy data for pregnant women. Yet many professional organizations have recognized the need for administration of COVID-19 vaccines in pregnancy and have issued their own set of recommendations. The lack of evidence, however, has often led to confused messaging, inconsistent language and differing recommendations across organizations, potentially contributing to delay or refusal to accept vaccination by pregnant women. We summarize those differences and recommend that leaders collaborate at a country level to produce joint recommendations. We use the example of Australia, where two professional authorities along with the government and partners in New Zealand worked towards one message, consistent language and a unified recommendation. The aim was to help health professionals and women who are planning pregnancy or who are currently pregnant or breastfeeding to make an informed decision about COVID-19 vaccination. National advisory groups for immunization, professional obstetric organizations and government bodies should be encouraged to coordinate their statements on COVID-19 vaccination for pregnant and lactating women and to use similar language and phrasing for greater clarity.
| S-EPMC8477428 | biostudies-literature
Project description:The acceleration of climatic, digital, and health challenges is testing scientific communities. Scientists must provide concrete answers in terms of technological solutions to a society which expects immediate returns on the public investment. We are living such a scenario on a global scale with the pandemic crisis of COVID-19 where expectations for virological and serological diagnosis tests have been and are still gigantic. In this Perspective, we focus on a class of biosensors (mechanical biosensors) which are ubiquitous in the literature in the form of high performance, sensitive, selective, low-cost biological analysis systems. The spectacular development announced in their performance in the last 20 years suggested the possibility of finding these mechanical sensors on the front line of COVID-19, but the reality was quite different. We analyze the cause of this rendez-vous manqué, the operational criteria that kept these biosensors away from the field, and we indicate the pitfalls to avoid in the future in the development of all types of biosensors of which the ultimate goal is to be immediately operational for the intended application.
| S-EPMC7574628 | biostudies-literature
Project description:ImportancePregnant women are at increased risk of morbidity and mortality from COVID-19 but have been excluded from the phase 3 COVID-19 vaccine trials. Data on vaccine safety and immunogenicity in these populations are therefore limited.ObjectiveTo evaluate the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women, including against emerging SARS-CoV-2 variants of concern.Design, setting, and participantsAn exploratory, descriptive, prospective cohort study enrolled 103 women who received a COVID-19 vaccine from December 2020 through March 2021 and 28 women who had confirmed SARS-CoV-2 infection from April 2020 through March 2021 (the last follow-up date was March 26, 2021). This study enrolled 30 pregnant, 16 lactating, and 57 neither pregnant nor lactating women who received either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines and 22 pregnant and 6 nonpregnant unvaccinated women with SARS-CoV-2 infection.Main outcomes and measuresSARS-CoV-2 receptor binding domain binding, neutralizing, and functional nonneutralizing antibody responses from pregnant, lactating, and nonpregnant women were assessed following vaccination. Spike-specific T-cell responses were evaluated using IFN-γ enzyme-linked immunospot and multiparameter intracellular cytokine-staining assays. Humoral and cellular immune responses were determined against the original SARS-CoV-2 USA-WA1/2020 strain as well as against the B.1.1.7 and B.1.351 variants.ResultsThis study enrolled 103 women aged 18 to 45 years (66% non-Hispanic White) who received a COVID-19 mRNA vaccine. After the second vaccine dose, fever was reported in 4 pregnant women (14%; SD, 6%), 7 lactating women (44%; SD, 12%), and 27 nonpregnant women (52%; SD, 7%). Binding, neutralizing, and functional nonneutralizing antibody responses as well as CD4 and CD8 T-cell responses were present in pregnant, lactating, and nonpregnant women following vaccination. Binding and neutralizing antibodies were also observed in infant cord blood and breast milk. Binding and neutralizing antibody titers against the SARS-CoV-2 B.1.1.7 and B.1.351 variants of concern were reduced, but T-cell responses were preserved against viral variants.Conclusion and relevanceIn this exploratory analysis of a convenience sample, receipt of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. Pregnant and nonpregnant women who were vaccinated developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.
| S-EPMC8120446 | biostudies-literature
Project description:Antivirals have demonstrated efficacy in treating other infectious diseases in early stages of disease, reducing morbidity, mortality, and the likelihood of onward transmission. At the time of writing, more than 1900 clinical trials are registered globally to assess the efficacy and safety of candidate therapeutics for COVID-19. The majority of these trials are designed to evaluate the comparative efficacy and safety of candidate therapeutics for the treatment of COVID-19 to prevent death among populations of hospitalized patients with advanced disease. Yet, emerging epidemiological evidence now indicates that the majority of those infected with the SARS-CoV-2, while still infectious, experience minimal or mild disease symptomology. Like HIV and hepatitis C that pioneered treatment as prevention, there is a missed opportunity for trials of early pharmaceutical intervention for COVID-19 disease evaluating not only reductions in morbidity and mortality but also transmissibility. We discuss this clinical research gap within an historical context of viral treatment as prevention for HIV and hepatitis C, and comment on the challenges and opportunities for clinical research of candidate therapeutics for early COVID-19 disease.
| S-EPMC7553378 | biostudies-literature
Project description:BackgroundAlthough mass vaccination against COVID-19 may prove to be the most efficacious end to this deadly pandemic, there remain concern and indecision among the public toward vaccination. Because pregnant and reproductive-aged women account for a large proportion of the population with particular concerns regarding vaccination against COVID-19, this survey aimed at investigating their current attitudes and beliefs within our own institution.ObjectiveThis study aimed to understand vaccine acceptability among pregnant, nonpregnant, and breastfeeding respondents and elucidate factors associated with COVID-19 vaccine acceptance.Study designWe administered an anonymous online survey to all women (including patients, providers, and staff) at our institution assessing rates of acceptance of COVID-19 vaccination. Respondents were contacted in 1 of 3 ways: by email, advertisement flyers, and distribution of quick response codes at virtual town halls regarding the COVID-19 vaccine. Based on their responses, respondents were divided into 3 mutually exclusive groups: (1) nonpregnant respondents, (2) pregnant respondents, and (3) breastfeeding respondents. The primary outcome was acceptance of vaccination. Prevalence ratios were calculated to ascertain the independent effects of multiple patient-level factors on vaccine acceptability.ResultsThe survey was administered from January 7, 2021, to January 29, 2021, with 1012 respondents of whom 466 (46.9%) identified as non-Hispanic White, 108 (10.9%) as non-Hispanic Black, 286 (28.8%) as Hispanic, and 82 (8.2%) as non-Hispanic Asian. The median age was 36 years (interquartile range, 25-47 years). Of all the respondents, 656 respondents (64.8%) were nonpregnant, 216 (21.3%) were pregnant, and 122 (12.1%) were breastfeeding. There was no difference in chronic comorbidities when evaluated as a composite variable (Table 1). A total of 390 respondents (39.2%) reported working in healthcare. Nonpregnant respondents were most likely to accept vaccination (457 respondents, 76.2%; P<.001) with breastfeeding respondents the second most likely (55.2%). Pregnant respondents had the lowest rate of vaccine acceptance (44.3%; P<.001). Prevalence ratios revealed all non-White races except for non-Hispanic Asian respondents, and Spanish-speaking respondents were less likely to accept vaccination (Table 3). Working in healthcare was not found to be associated with vaccine acceptance among our cohort.ConclusionIn this survey study of only women at a single institution, pregnant respondents of non-White or non-Asian races were more likely to decline vaccination than nonpregnant and breastfeeding respondents. Working in healthcare was not associated with vaccine acceptance.
| S-EPMC8146275 | biostudies-literature
Project description:BackgroundPregnant and lactating women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking.ObjectiveThis study aimed to evaluate the immunogenicity and reactogenicity of coronavirus disease 2019 messenger RNA vaccination in pregnant and lactating women compared with: (1) nonpregnant controls and (2) natural coronavirus disease 2019 infection in pregnancy.Study designA total of 131 reproductive-age vaccine recipients (84 pregnant, 31 lactating, and 16 nonpregnant women) were enrolled in a prospective cohort study at 2 academic medical centers. Titers of severe acute respiratory syndrome coronavirus 2 spike and receptor-binding domain immunoglobulin G, immunoglobulin A, and immunoglobulin M were quantified in participant sera (n=131) and breastmilk (n=31) at baseline, at the second vaccine dose, at 2 to 6 weeks after the second vaccine, and at delivery by Luminex. Umbilical cord sera (n=10) titers were assessed at delivery. Titers were compared with those of pregnant women 4 to 12 weeks from the natural infection (n=37) by enzyme-linked immunosorbent assay. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of women who delivered during the study period. Postvaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed-effects model, with correction for multiple comparisons, were used to assess differences among groups.ResultsVaccine-induced antibody titers were equivalent in pregnant and lactating compared with nonpregnant women (pregnant, median, 5.59; interquartile range, 4.68-5.89; lactating, median, 5.74; interquartile range, 5.06-6.22; nonpregnant, median, 5.62; interquartile range, 4.77-5.98, P=.24). All titers were significantly higher than those induced by severe acute respiratory syndrome coronavirus 2 infection during pregnancy (P<.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord than maternal sera, although this finding did not achieve statistical significance (maternal sera, median, 104.7; interquartile range, 61.2-188.2; cord sera, median, 52.3; interquartile range, 11.7-69.6; P=.05). The second vaccine dose (boost dose) increased severe acute respiratory syndrome coronavirus 2-specific immunoglobulin G, but not immunoglobulin A, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups.ConclusionCoronavirus disease 2019 messenger RNA vaccines generated robust humoral immunity in pregnant and lactating women, with immunogenicity and reactogenicity similar to that observed in nonpregnant women. Vaccine-induced immune responses were statistically significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.
| S-EPMC7997025 | biostudies-literature
Project description: Not available
| S-EPMC8547784 | biostudies-literature
Project description:Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.
| S-EPMC7184504 | biostudies-literature
Project description:BACKGROUND:For 30 years, women have sought equal opportunity to be included in trials so that drugs are equitably studied in women as well as men; regulatory guidelines have changed accordingly. Pregnant women, however, continue to be excluded from trials for non-obstetric conditions, though they have been included for trials of life-threatening diseases because prospects for maternal survival outweighed potential fetal risks. Ebola virus disease is a life-threatening infection without approved treatments or vaccines. Previous Ebola virus (EBOV) outbreak data showed 89-93% maternal and 100% fetal/neonatal mortality. Early in the 2013-2016 EBOV epidemic, an expert panel pointed to these high mortality rates and the need to prioritize and preferentially allocate unregistered interventions in favor of pregnant women (and children). Despite these recommendations and multiple ethics committee requests for their inclusion on grounds of justice, equity, and medical need, pregnant women were excluded from all drug and vaccine trials in the affected countries, either without justification or on grounds of potential fetal harm. An opportunity to offer pregnant women the same access to potentially life-saving interventions as others, and to obtain data to inform their future use, was lost. Once again, pregnant women were denied autonomy and their right to decide. CONCLUSION:We recommend that, without clear justification for exclusion, pregnant women are included in clinical trials for EBOV and other life-threatening conditions, with lay language on risks and benefits in information documents, so that pregnant women can make their own decision to participate. Their automatic exclusion from trials for other conditions should be questioned.
| S-EPMC5751665 | biostudies-literature
Project description:‘Autopsy studies are for the living and not the dead!’ This statement underlines the central role of autopsy studies in refining and informing the medical and forensic science body of knowledge. Significant outbreaks, like the ongoing COVID-19 pandemic, have continued to reveal the capacity gap in autopsy practice, especially in Sub-Saharan Africa (SSA). Despite the importance of autopsy in investigating previous infectious disease outbreaks, health systems in SSA still assign a lesser priority to autopsy and forensic practice. Some of the critical factors hindering routine clinical autopsy are the lack of experts and facilities, and a health system that focuses less on postmortem examination. Societal traditions and cultural beliefs against the practice of autopsy and manipulation of the dead body are also significant barriers. Nevertheless, strengthening the role of autopsy in clinical practice may help clinicians to more quickly address clinical questions associated with highly infectious outbreaks.
| S-EPMC7462550 | biostudies-literature